Hamilton General Hospital
Hamilton, Ontario, L8L 2X2, Canada
Location status: Recruiting
Location contact
Amanda Martyniuk, MSc
CONTACT
NCT Number: NCT03439228
The use of a lumbar brace following single-level lumbar fusion for degenerative spondylosis (non-traumatic) is variable between surgeons. Some surgeons prefer to prescribe a brace and others do not. There is a lack of guidelines and evidence to support either treatment option. The purpose of this study is to assess feasibility and collect preliminary data to conduct a larger, definitive trial to provide evidence as to whether prescribing a brace or not results in better or equal outcomes. Imaging by CT scan, one year after surgery, will be used to analyze bone fusion (healing), and functional and pain scores from patients during their recovery will be compared to identify differences between patients who wore a brace and those who did not.
Interested in participating?
Request Info18 year–80 year
All sexes
Interventional
Not applicable
Hamilton, Ontario, L8L 2X2, Canada
Location status: Recruiting
Amanda Martyniuk, MSc
CONTACT
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
3 months of lumbar brace wear
Time frame: 12 months
Feasibility measure to assess pilot project design. Assess ability to recruit 2 patients per month.
Time frame: 12 months
Feasibility measure to assess pilot project design. Evaluate study visit and study completion rates.
Time frame: 12 months
Status of bone fusion assessed radiologically by CT scan
Time frame: 3 months, 6 months, 12 months
The Oswestry Disability Index
Time frame: 3 months, 6 months, 12 months
Visual analog scale (0, no pain to 10, worst pain)
Contact information is provided by the study sponsor or research team.
Hamilton Health Sciences Corporation
Other
To Brace or Not to Brace for Single Level Lumbar Fusion: a Pilot Prospective Randomized Controlled Trial
Acronym: BRACE Pilot
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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